(Associate) Director QA GMP

The organisation

Your new company is based in the Amsterdam area and focuses on making the future of medicine better using gene therapy. By doing so, they help patients with serious unfulfilled medical needs. This means that you will, indirectly, contribute to helping those patients and potentially giving them a better life. On a daily basis you will contribute to this as well. The company is continuously looking for highly motivated and skilled people who are willing to make a difference.

The position

As an (Associate) Director QA GMP you will support the day-to-day GMP operations via oversight of all elements of the Quality Management System (QMS), including deviations, Corrective and Preventive Actions (CAPAs), investigations, excursions, Out of Specifications (OOS), change control, and data integrity in support of biologics manufacturing production. Your responsibilities also include supporting/conducting internal audits and managing and supporting any regulatory agency or third-party inspections. Other tasks include:

• Supporting cGMP Manufacturing, Engineering, Validation, Supply Chain, and QC laboratory operations through administration and enforcement of the Quality Management System including deviations, change controls, and CAPAs.
• Responsibility for tracking and trending QMS metrics including those related to deviations, CAPA, Change Controls, OOS, and internal/external audits performance.
• Supporting the supplier quality program through review and approving of vendor change notifications, part number requests, raw material specifications, and raw material release.
• Conducting and assisting in internal audits against applicable quality system standards and regulations.
• Managing any regulatory agency or third-part inspections.
• Representing the Quality Assurance department on project teams and in meetings.
• Supporting the continuous improvement and oversight of Quality Management System procedures.
• Mentoring junior QA staff. You will have 3 direct reports: a QA Engineer, a QA/QA Specialist and a QA Manufacturing Specialist.

Candidate profile

To be successful as an (Associate) Director QA GMP, you have a Bachelor’/Master’s Degree in Life Sciences or Engineering, combined with 10+ years of relevant GMP experience in a pharma/biotech company. You have experience working within a quality system and in a regulated GMP environment. You are well versed in cGMP/ICH/FDA/EU regulations and guidelines. If you also have Internal and/or external audit and Regulatory inspection experience this will be considered a plus. IT wise you need to be proficient in using Microsoft applications (MS Word, MS Excel, MS Powerpoint). You are fluent in English, Dutch is not mandatory for this position. You need to be available fulltime (40 hours per week) for this position and your presence is requested on site in Amsterdam.

The offer

You will work in an international and dynamic environment with many opportunities to grow your career for the long term. The salary depends on your education and experience and they offer great secondary benefits, such as 30 holidays, travel expenses, stock options, a good pension scheme, a monthly allowance for your health insurance, an annual personal education budget and a company fitness plan. It’s an amazing environment, will you join them as a (Associate) Director QA GMP?

Interested?

You can apply to this position by using the link below.